A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
2期
进行中(已停止招募)
NCT03698019
| 适应症 | Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Mucosal Melanoma |
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| 分期 | 2期 |
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| 申办方 | National Cancer Institute (NCI) |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 313 人 |
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| 干预(药物) | Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Pembrolizumab, Therapeutic Conventional Surgery |
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| 开始日期 | 2019年2月15日 |
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| 完成日期 | 2022年9月1日 |
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| 结果公布日 | 2023年11月21日 |
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摘要
This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.
Two-Year Event-Free Survival Rate
2 years · percentage of participants
| Arm I (Adjuvant Pembrolizumab) | 49 percentage of participants |
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| Arm II (Adjuvant and Neoadjuvant Pembrolizumab) | 72 percentage of participants |
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| p-value | 0.004 |
| Hazard Ratio (HR) | 0.64 |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。